Remicade Biosimilar Closer To Approval, But Patent Dance Goes On

Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product cleared a significant regulatory hurdle on February 9, 2016, when the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee voted 21-3 in favor of approval. While the FDA is not bound by the Advisory Committee’s decision, it is expected to follow the recommendation and approve the product. However, other requirements of the Biologics Price Competition and Innovation Act (BPCIA) and Janssen’s patents may keep Celltrion’s product off the market for a while longer. Continue reading this entry

Federal Circuit Finds No "Way" To Support Doctrine Of Equivalents

In Akzo Nobel Coatings, Inc. v. Dow Chemical Co., the Federal Circuit upheld the district court’s grant of summary judgment of no infringement under the doctrine of equivalents because the patent holder had failed to establish a genuine issue of material fact under the function-way-result test. This case illustrates the scrutiny the court may apply to expert testimony cited to support infringement under the doctrine of equivalents.  Continue reading this entry

Asset Transferee Cannot Appeal Reexamination

The Federal Circuit dismissed the appeal in Agilent Technologies, Inc. v. Waters Technologies Corp., because the appellant was not a “third-party requester” dissatisfied with the final decision in an inter partes reexamination proceeding, as required by 35 USC § 141. Although Agilent was a transferee of relevant assets, it had not shown that it was the successor-in-interest to the original third-party requester. The same statute affords the right to appeal final decisions in post grant review and inter partes review proceedings, but different language may prove more flexible. Continue reading this entry

Purdue OxyContin Patents Invalid Despite Stemming From Discovery Of Source Of Toxic Impurity

In Purdue Pharma L.P. v. Epic Pharma LLC, the Federal Circuit affirmed the district court decision holding four OxyContin patents invalid as obvious. In so doing, the court rejected Purdue’s arguments that its discovery of the source of the toxic impurity that was minimized in the claimed products did not support patentability, because the solution to the problem did not depend on the source of the impurity.  Continue reading this entry

Incomplete Restriction Requirement Stops Clock For Patent Term Adjustment

In Pfizer v. Lee, the Federal Circuit affirmed the decision of the U.S. District Court for the Eastern District of Virginia that upheld the USPTO’s Patent Term Adjustment (PTA) calculation that stopped the clock running against the USPTO when the examiner issued an incomplete Restriction Requirement. This decision is not surprising, but Applicants should remember that they are held to a different standard under the PTA rules. Continue reading this entry